This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.
Age between 14 days and 90 days.
Healthy singleton term infants born between 37 weeks and 42 weeks of gestation.
Infants who have received CMF for at least 7 consecutive days.
Exclusive formula feeding.
Exclusively or partially feeding with human milk
Introduced to solid food, supplementary feeding, use of pre- and/or probiotics as a supplement
Congenital or recurrent chronic conditions and/or malabsorption that could interfere with study parameters.
Diagnosed cow's milk allergy (CMA) or suspected to have CMA, soy allergy, fish allergy, egg allergy and/or lactose intolerance.
Parallel
Goat milk-based infant formula
Other interventionStudy product is administered on demand until the age of 6 months.
Cow's milk-based infant formula
Other interventionStudy product is administered on demand until the age of 6 months.
Gastrointestinal symptoms as determined by CoMiSS
The CoMiSS® is a simple, fast, and easy-to-use awareness tool for cow's milk-related symptoms and may be used in clinical trials to evaluate and quantify the severity of symptoms during a feeding trial. The CoMiSS scores symptoms in five different domains: Crying, Regurgitation, Stools, Skin and Respiratory. The CoMiSS score ranges from 0 to 33 with score 0 as best score (no symptoms) and 33 as worst score (severe symptoms).
Gastrointestinal tolerance as determined by IGSQ
The IGSQ is a 13-item self-report instrument that has been used in clinical trials to assess infants' GI-related signs and symptoms observed by their parents over the previous week in 5 domains: stooling, regurgitation/vomiting, flatulence, crying, and fussiness. The IGSQ has a possible range of 13 to 65, where higher values indicate greater GI distress and values ≤ 23 indicate no digestive distress.
Gastrointestinal symptoms throughout the study as determined by CoMiSS
The CoMiSS® is a simple, fast, and easy-to-use awareness tool for cow's milk-related symptoms and may be used in clinical trials to evaluate and quantify the severity of symptoms during a feeding trial. The CoMiSS scores symptoms in five different domains: Crying, Regurgitation, Stools, Skin and Respiratory. The CoMiSS score ranges from 0 to 33 with score 0 as best score (no symptoms) and 33 as worst score (severe symptoms).
Gastrointestinal tolerance throughout the study as determined by IGSQ
The IGSQ is a 13-item self-report instrument that has been used in clinical trials to assess infants' GI-related signs and symptoms observed by their parents over the previous week in 5 domains: stooling, regurgitation/vomiting, flatulence, crying, and fussiness. The IGSQ has a possible range of 13 to 65, where higher values indicate greater GI distress and values ≤ 23 indicate no digestive distress.
Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari
The Vesikari Clinical Severity Scoring System includes a e-diary card completed by parents, to identify rotavirus gastroenteritis episodes. The Vesikari Clinical Severity Scoring System Parameters score ranges from 0 to 20 with score \<7 as mild symptoms and score 10 to 20 as severe symptoms.
Occurrence, duration and severity of respiratory infections as determined by CARIFS
Canadian Acute Respiratory Illness and Flu Scale is a validated parental questionnaire, to measure the disease severity of children with acute respiratory illness (ARI) including influenza. CARIFS consists of 18 items covering three domains; symptoms (e.g., cough); function (e.g., play), and parental impact (e.g., clinginess). Each item is scored 0 to 3, with higher scores indicating greater severity of illness. The full scale ranges from 0 to 58. For children older than 5 years the full scale is used; for children younger than 5 years, 3 items (headache, sore throat, and muscle aches) are not used for assessment.
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